NCT01963312已完成不适用
A Randomised Clinical Trial to Compare Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate Compared Versus the Transurethral Resection of the Prostate to Treat the Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia.
Fundacion Miguel Servet2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2014年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Maximum urinary flow (Qmax)
研究概览
简要总结
The purpose of this study is to determine whether the transarterial supraselective embolization (TSE) is a technique as effective as transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of benign prostatic hyperplasia with moderate or severe obstructive lower urinary tract symptoms
- •Refractory to medical treatment for at least 6 months
- •Qmax (maximum urinary flow) less than 10 mL/second
排除标准
- •Patients not candidates for transurethral resection of the prostate (TURP)
- •Advanced atherosclerosis and tortuosity of the iliac arteries
- •No visualization of the prostatic artery CT angiography study
- •Urethral stenosis, detrusor failure or neurogenic bladder
- •Glomerular filtration < 30 mL/min
- •Presence of malignant tumor
- •History of allergy to iodinated contrast
- •Patients with any other medical or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
研究组 & 干预措施
Transarterial Supraselective Embolization
Experimental
Transarterial supraselective embolization of prostatic arteria with Bead Block 300-500 μm
干预措施: Transarterial Supraselective Embolization of the prostate (Procedure)
Transurethral Resection
Active Comparator
Surgery to remove part of the prostate gland
干预措施: Transurethral Resection of the prostate (Procedure)
结局指标
主要结局
Maximum urinary flow (Qmax)
时间窗: 12 months
Maximum urinary flow (Qmax) measured prior intervention and one year later
次要结局
- Reduction in prostate volume(12 months)
- Sexual function(12 months)
- International Prostate Symptom Score (IPSS) measured before and after the intervention(12 months)
研究者
研究点 (2)
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